Senior Regulatory Affairs Associate
3 days ago
Bring your expert knowledge of Health Canada regulatory requirements and guidelines to Parexel
We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of Health Canada regulatory requirements and processes to a major, dedicated client partnership.
As a Senior Regulatory Affairs Associate, you will serve as the primary regulatory liaison with local health authorities (HAs), industry groups, and internal stakeholders. In this role, you will lead regulatory processes, ensure compliance with national legislation, and provide critical support for product launches, integrations, and lifecycle management activities.
This is a dynamic position that demands deep regulatory expertise, strong project management capabilities, and the ability to effectively influence
cross‑functional teams in a fast‑changing environment.
Key Responsibilities
Documentation & Compliance
- Prepare, organize, and coordinate local documentation (e.g., Module 1) to meet national submission requirements.
- Maintain and update national systems in line with local legislation (renewals, PSURs, label updates, CMC changes).
- Execute timely data entry and validation in Veeva Vault RIMS for submissions and approvals.
Regulatory Submissions
- Review, prepare, and submit dossiers; negotiate with HAs to secure approvals.
- Provide local input for change control and post-approval requirements.
- Collaborate with global functions to obtain documentation aligned with local requirements.
Audit & Inspection Support
- Support RA representatives during audits/inspections, ensuring readiness and timely CAPA closure.
- Provide local expertise and responses to inspection queries.
Cross-Functional Collaboration
- Partner with Regulatory, Medical, Marketing, and Market Access teams to assess and mitigate impacts of regulatory changes.
- Act as the primary RA representative for local Commercial and Medical teams, translating business needs into actionable regulatory strategies.
Strategic Leadership
- Lead regulatory strategies for product launches and integrations at the affiliate level.
- Represent the company with local HAs, industry groups, and trade associations, fostering positive relationships.
- Provide critical support for promotional material review, interpretation of regulations, and implementation of local legislation.
Education
- Bachelor's degree in natural sciences (biology, chemistry with pharmacological focus) or equivalent.
- Advanced degree (Master's or PhD) preferred in law, legal affairs, or natural sciences.
- Regional Regulatory Affairs Certification (RAC, CARP, CHPC) is a plus.
Experience
- 3–5+ years of local regulatory knowledge and experience in a health authority-facing role.
- Comprehensive understanding of regional and global regulatory requirements, guidelines, and processes.
- Proven expertise in managing regulatory submissions, timelines, and cross-functional teams.
- Strong project management and leadership skills.
- Experience influencing Commercial Operations stakeholders and driving business-critical decisions.
- Demonstrated ability to adapt and succeed in rapidly changing environments.
-
Senior Associate Regulatory Affairs
1 week ago
Downtown Toronto, Ontario, Canada Attaineo Full time $80,000 - $120,000 per yearReporting to the Regulatory Affairs Director, the Senior Associate Regulatory Affairs will prepare regulatory submissions for complex injectable generic products and biosimilars; and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements. The Senior Associate Regulatory Affairs will...
-
Senior Associate, Regulatory Affairs PLCM
1 week ago
Toronto, Ontario, Canada Fresenius Kabi Canada Full time US$80,000 - US$120,000 per yearJob DescriptionAs a global healthcare company, Fresenius Kabi isCommitted to Life. The company's products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 41,000 employees and presence in over 100 countries, Fresenius Kabi's expansive product portfolio focuses on providing access to...
-
Toronto, Ontario, Canada Johnson & Johnson Full timeAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...
-
Toronto, Ontario, Canada Johnson & Johnson Innovative Medicine Full timeAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...
-
Toronto, Ontario, Canada Johnson & Johnson Innovative Medicine Full timeAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...
-
Toronto, Ontario, Canada myGwork - LGBTQ+ Business Community Full timeThis job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,...
-
Senior Manager, Regulatory Affairs
4 days ago
Toronto, Ontario, Canada Hydro One Full timeToronto - Regular .Hydro One is proud to be the largest electricity transmission and distribution provider in Ontario, serving nearly 1.5 million customers. We have a long history in the industry with our roots dating back over 110 years to 1906. Since then, we have worked to grow and evolve to meet the changing needs of our customers and communities...
-
Toronto, Ontario, Canada DECIEM | THE ABNORMAL BEAUTY COMPANY Full time $100,000 - $120,000 per yearWHAT ON EARTH IS DECIEM?Known as "The Abnormal Beauty Company", DECIEM is the parent company of The Ordinary, NIOD, and other beauty brands & is an industry disruptor with a science first approach to innovation. DECIEM was Co-Founded in 2013 by the late Brandon Truaxe, a visionary who set out to change the beauty industry through authenticity and...
-
Regulatory Affairs Specialist
3 days ago
Toronto, Ontario, Canada Give & Go Prepared Foods Corp. Full timeGive & Go Prepared Foods a proud member of the Mondelēz family. We are a leading, and growing, North American manufacturer of baked goods for over 30 years. If you're looking for a company that will provide you with opportunities for career growth and development, while working with an energetic and team with deeply ingrained values of respect, direct and...
-
Regulatory Affairs Specialist
4 days ago
Toronto, Ontario, Canada A Hiring Company Full timeRegulatory & ComplianceParticipates in the evaluation of products for compliance with health and safety, storage, transportation and end-user specific application; validating product listings and product claims align with regulatory requirements.Works within the framework of a variety of legislative bodies, including, but not limited to:The Canadian...
